A Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy of Synbiotic 365 on Body Composition in Overweight and Obese Individuals.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Change in body mass index (BMI) and the percentage of body fat f
研究概览
简要总结
Evaluate the effect of Synbiotic 365 (Version 5 and 7) on body composition in overweight and obese individuals as measured by change in body mass index (BMI) and the percentage of body fat from Day 0 to Day 84 when compared to placebo by Dual Energy X-ray Absorptiometry scan (DEXA) for body composition (Body Mass Index, Lean Body Mass, Body Fat, Fat Free Mass).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in body mass index (BMI) and the percentage of body fat f
时间窗: Day 0 (Baseline) to Day 84
To investigate the effect of Synbiotic 365 (Version 5 and 7) on body composition in overweight and obese individuals as measured by change in body mass index (BMI) and the percentage of body fat from Day 0 to Day 84 when compared to placebo by Dual Energy X-ray Absorptiometry scan (DEXA) for body composition
次要结局
- • Change in coronary risk in comparison to placebo on day 84 from baseline.(Day 0 (Baseline) to Day 84)
- • Change in central obesity in comparison to placebo on day 28, 56 and 84, from baseline as assessed by the anthropometric index of waist-to-hip ratio.(Day 0 (Baseline) to Day 84)
- • Change in blood glucose metabolism in comparison to placebo on day 84 from baseline as assessed by HOMA-IR [(fasting Glucose x fasting Insulin) /405)].(Day 0 (Baseline) to Day 84)
- • The change in liver and renal safety parameters.(Day 0 (Baseline) to Day 84)
- • Adverse and serious adverse events recorded during the study duration on IP consumption, as compared to placebo.(Day 0 (Baseline) to Day 84)
- • Total body weight change in comparison to placebo on day 28, 56 and 84, from baseline, as assessed by weighing scale method.(Day 0 (Baseline) to Day 84)
- • Change in health-related quality of life (HRQL) scores in comparison to placebo on day 28, 56 and 84 from baseline, as assessed by Gastrointestinal Quality of Life Index (GIQLI).(Day 0 (Baseline) to Day 84)
- • Change in systemic inflammation in comparison to placebo on day 84 from baseline as assessed by hs-CRP test.(Day 0 (Baseline) to Day 84)
- • Change in satiety in comparison to placebo on day 28, 56 and 84, from baseline as assessed by the Three-Factor Eating Questionnaire (TFEQ) for satiety.(Day 0 (Baseline) to Day 84)
- • The change in vital signs monitoring on all the study visits from baseline.(Day 0 (Baseline) to Day 84)